Nxera Pharma has struck an exclusive licensing deal with Santhera Pharmaceuticals to develop and commercialize the duchenne muscular dystrophy (DMD) treatment vamorolone across Japan, South Korea, Australia and New Zealand, significantly expanding its rare disease portfolio in the Asia-Pacific region.

 

Under the agreement, Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories. 

 

Vamorolone is already approved and marketed as AGAMREE in the US, European Union, UK and China for DMD, a rare inherited neurodegenerative disease. The deal adds a late-stage asset to Nxera’s growing slate of specialty medicines, which includes PIVLAZ and QUVIVIQ, both already approved in Japan.

 

Nxera said the partnership builds on its established regulatory and commercial footprint across APAC, as well as its prior experience with vamorolone through its 2023 acquisition of Idorsia’s Japan and APAC business. The company positions the therapy as a potential advance over existing steroid treatments for DMD patients in the region.

 

Christopher Cargill, President and Chief Executive Officer of Nxera, commented: “We are excited to partner with Santhera to bring vamorolone to DMD patients in Japan, South Korea, Australia and New Zealand. Vamorolone’s differentiated safety and efficacy profile has the potential to fundamentally change the standard of care by enabling early use, full dosing, and long-term treatment, addressing critical limitations of existing steroid therapies currently used in the region.

 

“Furthermore, the transaction expands our portfolio of late- and commercial-stage products for Japan/APAC and advances our mission to bring innovative medicines to patients in these important regions in line with our 2030 vision to build high-growth, highly profitable Japanese biopharma company.”

 

Santhera said the deal marks a key step in broadening global access to AGAMREE and accelerating uptake in high-value markets.

 

Dario Eklund, Chief Executive Officer of Santhera, added: “This strategic partnership represents a significant milestone in our mission to expand global access to AGAMREE® (vamorolone) and bring meaningful new treatment options to patients with DMD worldwide. 

 

"Nxera's deep expertise and established infrastructure in Japan and across the wider APAC region, as well as prior experience of vamorolone, make them an ideal partner to unlock the full commercial and clinical potential of AGAMREE (vamorolone) in these markets and accelerate access for patients with DMD.”